Romiplostim (roe-mi-PLOE-stim)

Treats immune thrombocytopenia (ITP) and acute radiation syndrome (high levels of radiation).

Brand Name(s):

Nplate

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot under your skin.
• A nurse or other health provider will give you this medicine.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Call your doctor or pharmacist for instructions. A missed dose could increase your risk for bleeding.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant, or if you have liver disease, bleeding problems, bone marrow problems (including a blood cancer or myelodysplastic syndrome [MDS)], or a history of blood clots. Tell your doctor if you also have had surgery to remove your spleen (splenectomy).
• Do not breastfeed during treatment with this medicine.
• This medicine may cause the following problems:
  • Worsening of MDS to leukemia (white blood cell cancer)
  • Increased risk of blood clots (including portal vein thrombosis)
• Your condition can cause you to bleed too much when injured. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Chest pain, trouble breathing, coughing up blood
• Fever, cough, stuffy or runny nose, sore throat
• Pinpoint red spots on the skin
• Sudden or severe headache, problems with vision, speech, or walking
• Unusual bleeding, bruising, or weakness, blood in the urine or stools
• Weakness in your arm or leg, or on one side of your body, pain in your lower leg (calf)

If you notice these less serious side effects, talk with your doctor:

• Headache, dizziness, trouble sleeping
• Indigestion, diarrhea, stomach pain or upset
• Muscle or joint pain, pain in your shoulders, arms, or legs
• Numbness, tingling, or burning pain in your hands, arms, legs, or feet
• Redness, pain, swelling, itching, blistering, or rash where the shot was given

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088